Transboundary movement of genetically modified organisms (GMOs). Cartagena Protocol on Biosafety

The committee adopted the report by Jonas SJÖSTEDT (EUL/NGL, S) amending the proposed regulation under the codecision procedure (1st reading). It felt that the Commission had taken a very minimalist approach in its proposal and had failed, in certain instances, to do justice to the Cartagena Protocol's essential requirements. It also sought to clarify some aspects of the proposed regulation and adopted a whole set of "Cartagena plus" rules, underlining that, while the Cartagena Protocol set the framework for transboundary movements of GMOs, it did not prevent Parties from taking more pro-active steps to ensure international biosafety. Therefore, although the Protocol and the Commission proposal did not lay down any rules requiring a notification procedure for exports of food and feed "produced from or with the aid of GMOs" and for exports of GMOs intended for contained use, the committee proposed to extend the scope of the regulation so that such exporters would be required to comply with the laws and rules of the importing country, which may require such notification. It also stipulated that a full notification procedure should be required prior to any first transboundary movement of GMOs intended for direct use as food, feed or for processing, if the country of import so required. Another amendment required exporters to comply with the laws and rules of Parties of transit regarding the transit of GMOs. A number of the amendments sought to bring the proposed regulation more into line with the Protocol, in some cases by incorporating certain sections of the Protocol verbatim. For example, one amendment aimed at a narrower exclusion of "pharmaceuticals for human use" from the export notification procedure, based on the Protocol's more precise definition of pharmaceuticals to be excluded from its jurisdiction. The committee also sought to delete the category of "notifier" in the proposal on the grounds that, given the Commission's definition of "exporter" and "notifier", it would be the notifier rather than the exporter who would be responsible for the accuracy of the information contained in the notification. As the Protocol made it clear that any representative mandated by the exporter to take care of the paperwork always acted on behalf of the exporter, the committee argued that the exporter thus retained clear legal competence and liability. The category of notifier should therefore be removed from the proposal, and the definition of "exporter" should be reworded in line with the Protocol. Another amendment sought to clarify the issue of the export of GMOs intended for release into the environment, to take account of the fact that most such GMOs will not be released immediately on reaching the territory of the Party of import. In keeping with the spirit of the Protocol, it stipulated that prior written consent by the country of import would be required for the first intentional transboundary movement of a GMO "intended directly or indirectly for deliberate release into the environment", in other words, an export notification was needed irrespective of the stage at which the release of the GMO would take place. The committee also adopted amendments on access to information requiring the Commission to make substantial parts of export notifications publicly available while at the same time protecting the legitimate commercial interests and intellectual property rights of the exporter. It stipulated that the information which may not be kept confidential included a general description of the GMO or GMOs, the name, address and contact details of the exporter and importer, the purpose of the release, location of release and intended uses, environmental risk assessment, methods and plans for monitoring the GMO or GMOs and for emergency response, and the quantity or volume of the GMOs to be transferred. �